Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05070637 |
| Other study ID # |
0001 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 27, 2021 |
| Est. completion date |
May 18, 2022 |
Study information
| Verified date |
November 2022 |
| Source |
Hospital de Santa Maria, Portugal |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This study will study circulating tumor cell (CTC) release during laparoscopic radical
nephrectomy (LRN) for RCC. The main objective is to determine if CTC release can be reduced
during RN by using a no-touch technique, with an early renal pedicle ligation. The
investigators also aim to describe the CTC profile in terms of CTC count (CTCn),
epithelial/mesenchymal status, and CTC cellular features in renal cell carcinoma (RCC)
patients, stratified by "primary tumor, regional nodes, metastasis" (TNM) staging,
histological subtype, and other clinical and radiological features.
Patients undergoing RN will enter a two-arm prospective single-center randomized controlled
trial (RCT), comparing a no-touch RN technique, with direct pedicle ligation (Group A) vs.
the more conventional approach of kidney traction and manipulation to reach the renal pedicle
before its ligation (Group B).
A microfluidic size-based CTC isolation device will be used to capture and count CTCs from
peripheral blood samples of these patients. CTCs will be identified by staining with
antibodies to cytokeratin 8/18, vimentin, 4',6-diamidino-2-phenylindole (DAPI), and cluster
of differentiation antigen 45 (CD45).
CTC release will be correlated with the disease-free survival (DFS), and overall survival
(OS). The investigators will determine if CTC reducing no-touch radical nephrectomy technique
improves these hard outcomes.
Description:
This study will study CTC profile in RCC, and their release into the blood circulation during
LRN.
Included patients will be referred to the Renal Cancer Unit of the North Lisbon University
Hospital Center (CHLUN) Urology Department with the diagnosis of a renal mass eligible for a
LRN. Patients will have their diagnosis confirmed, be appropriately staged, and their
management options will be decided after a shared and informed decision process in light of
the current European Association of Urology (EAU) Guidelines on RCC. Patients < 18 years old
and pregnant women will be excluded. Patients will be adequately informed of the study
protocol, and will sign a specific informed consent.
Patients undergoing LRN will enter a two-arm prospective single-center randomized controlled
trial, comparing a no-touch technique, with direct pedicle ligation (Group A) vs. the
conventional dissection, and ligation of the renal pedicle with kidney traction (Group B). A
peripheral blood sample will be collected at arrival to the operating room. After that, Group
A patients will undergo a no-touch RN, with the dissection being done through the Gerota's
fascia plane until exposure of the corresponding great vessel (vena cava on the right side,
and aorta on the left side) is obtained. The renal pedicle will be directly isolated, and
ligated using Weck® clips with no kidney manipulation. Group B patients will undergo a more
conventional approach, starting with opening of the Gerota's fascia, identification of the
ureter, traction on the peri-renal fat below the ureter while dissecting cephalad until the
renal pedicle is reached. The renal pedicle will then be isolated while maintaining traction
on the kidney, and peri-renal fat, and ligated using Weck® clips. A second peripheral blood
sample will be collected at the time of specimen extraction. A third and fourth peripheral
blood samples will be collected at post-operative days 1 and 30, respectively, to study CTC
post-op kinetics. All samples will collect 7.5 mL of peripheral blood.
Patients presenting with hypofunctioning kidneys with indication for total nephrectomy will
be used as controls. Total nephrectomy patients will undergo the randomization protocol, in a
control arm.
The CTCs will be isolated from peripheral blood samples using a microfluidics size-based CTC
capture device - Ruby™. Whole blood samples will be injected into the devices at an 80 µL/min
flow rate. The CTCs captured on the devices will then be stained with antibodies to
4',6-diamidino-2-phenylindole (DAPI) to identify cell nuclei, cluster of differentiation
antigen 45 (CD45) to identify leukocytes, cytokeratin 8/18 to identify epithelial CTCs, and
vimentin to identify mesenchymal CTCs or CTCs which have undergone epithelial-to-mesenchymal
transition. Blood samples will be processed no more than 30 minutes after collection.
